| CTRI Number |
CTRI/2023/07/055623 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see relation between insertion torque and implant stability quotient in dental implants at different bone types or densities. |
|
Scientific Title of Study
|
Correlation of insertion torque and implant stability quotient at different bone densities in dental implants : A prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANKITA GHANSHYAM TODSAM |
| Designation |
post graduate student |
| Affiliation |
Terna dental college and hospital |
| Address |
Department of oral and maxillofacial surgery, room number 131, Terna Dental college and Hospital, nerul west, navi mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9404306345 |
| Fax |
27721698 |
| Email |
ankita.todsam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SACHIN BAGADE |
| Designation |
Associate professor |
| Affiliation |
Terna Dental College And Hospital |
| Address |
Department of oral and maxillofacial surgery, room number 131, Terna Dental college and Hospital, nerul west, navi mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9373259301 |
| Fax |
27721698 |
| Email |
drsachinbagade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Ghanshyam Todsam |
| Designation |
post graduate student |
| Affiliation |
Terna Dental College And Hospital |
| Address |
Department of oral and maxillofacial surgery ,room number 131, Terna Dental college and Hospital , nerul west, navi mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
09404306345 |
| Fax |
27721698 |
| Email |
ankita.todsam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna Dental college and Hospital, nerul west, navi mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Ghansham Todsam |
| Address |
Department of oral and maxillofacial surgery ,room number 131, Terna Dental college and Hospital , nerul west, navi mumbai |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Ghanshyam todsam |
Terna Dental college and Hospital |
Department of oral and maxillofacial surgery, room no. 131, terna dental college and hospital, nerul west, navi mumbai - 400706
Thane
MAHARASHTRA |
09404306345
27721698
ankita.todsam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient who want replacement of missing teeth using implants |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the study.
2. Patients over 18 years of age.
3. Patients with edentulous or partially edentulous arch.
4. Patients who have an alveolar ridge with sufficient vertical and horizontal
dimensions. (not requiring bone graft)
5. Patients with good oral health and free of periodontal diseases (bone and gingival
tissues must be healthy).
6. Absence of periapical lesion around the apex of the tooth.
7. Jaw regions with bone density (D1-D4 bone density) based on CBCT findings.
8. Patients who will be well motivated for the dental implant therapy and will be
available for the follow-up visits |
|
| ExclusionCriteria |
| Details |
1. Patients with Metabolic bone disease.
2. Patients undergone radiotherapy in the head/neck region in the last 24 months.
3. Alcohol or drug abuse.
4. Pregnant and lactating female patients.
5. Any drug that compromise the healing of bone like corticosteroids or
Bisphosphonates.
6. Patients with history of any uncontrolled systemic disease or local condition that
compromises the bone healing potential such as heavy smoking , uncontrolled
diabetes mellitus, immunocompromised patient, uncontrolled bleeding disorder.
7. Patients with serious psychiatric or psychological problems.
8. patient who needed immediate or early loading.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess correlation between insertion torque & implant stability quotient. |
at the time of placement of implant(initial) & three months after (final) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess correlation between insertion torque & bone density.
To assess correlation between implant stability quotient & bone density |
at baseline & 3 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental implants are currently accepted as a most predictable treatment option for the
rehabilitation of both partial or total edentulous patients. During the early phases of
healing, dental implants should be protected from detrimental micromovements which,
according to the literature, should not exceed values ranging from 50 and 150 μm to avoid
risks for the osseointegration. When exceeding this threshold, there is a concrete
possibility that the bone implant interface could be colonized by fibroblasts from the
overlying connective tissue, with consequent implant encapsulation in fibrous tissue and
clinical failure. Numerous noninvasive methods have been proposed to evaluate implant stability, but the
most widespread techniques are implant insertion torque measurement (IT) and
resonance frequency analysis (RFA). Till date, insertion torque value (ITV) and implant stability quotient (ISQ) obtained by the
Osstell instrument are common clinical methods to assess the initial stability of an implant
for a predictable loading procedure. Primary stability is described as the result of bone compression during implantation. Good
primary stability is essential for the prevention of implant micro-movements and in order
for bone remodeling and osseointegration around the implant to be achieved. Secondary stability is referred to as biological stability that develops as a consequence of
the formation and remodeling of alveolar bone on the implant surface . There are three protocols for implant loading: (1) immediate loading, prosthesis may be placed in occlusion up to 72 hours after implant
placement. (2) early loading, prosthesis may be placed in occlusion between 1 week and 2 months
after implant placement. (3) delayed loading, prosthesis may be placed in occlusion from 3 to 8 months after implant
placement. Insertion torque was developed by Johansson and Strid and improved by Frieberg in the
1990s.According to Baldi et al, the insertion torque is applied with a torque wrench, and it
is the measure of the frictional resistance encountered by the implant while moving
forward apically through a rotatory movement on its axis. Thus, this method provides
information about bone quality at the implant placement site and implant primary
stability. The RFA was developed in the late 1990s by Meredith. The RFA methodology is based on
the quantitative assessment of implant micro deflection. According to Herrero-Climent et
al, the RFA is a noninvasive diagnosis technique that uses a piezoelectric transducer, which
emits a sinusoidal signal within a specific frequency, resulting in implant vibration. The
implant resistance to vibration is measured by the device and transformed into the implant
stability quotient (ISQ, within a 0–100 scale; 100 being maximum implant stability).
Clinically, RFA has been used to assess the implant primary stability and stability over time.
Therefore, the RFA allows to check and identify the risk of failure of an implant before it
occurs. |